MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH; INFLATABLE PENILE PROSTHESIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

The following information was obtained from a literature article titled surgical technique for complex cases of peyronie's disease with implantation of penile prosthesis, multiple corporeal incisions, and grafting with collagen fleece" dates noted in the article were: received august 25, 2018.Accepted november 30, 2018.Copyright 2019.16 patients were implanted with a genesis malleable device (reported under 2125050-2020-00348).27 patients were implanted with an ipp (either a non-coloplast ipp or a titan touch device).The patients were implanted between february 2015 and may 2018.The average patient age for the ipp implants was 52.6.Per the article, the following complications were reported for ipps (however, it is unknown if each of these occurred with a titan touch or a non-coloplast device): 1 infection, which was resolved with the mulcahy salvage procedure and the replacement of the inflatable device 6 hematomas were recorded.All hematomas (or bruising) resolved.In addition, 12 patients had glans hypoesthesia at the 6-week revision.It was not reported which device (malleable or ipp) each of these patients was implanted with.No ipp patients were reported to have glans numbness at 6 months.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 9997990
• MDR Text Key: 193353876
• Report Number: 2125050-2020-00347
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 53 YR